Generic Name and Formulations:
Mesalamine 400mg; del-rel caps.
Indications for DELZICOL:
Mildly to moderately active ulcerative colitis (UC) in patients ≥5 years of age. Maintenance of remission of UC in adults.
Swallow caps whole; if unable to swallow, may open and swallow contents (four 100mg tabs). Treatment: 800mg 3 times daily for 6 weeks. Maintenance: 1.6g/day in 2–4 divided doses. Two Delzicol 400mg caps are not bioequivalent to one mesalamine 800mg del-rel tab.
<5yrs: not established. Give twice daily dosing for 6 weeks. ≥5yrs (17–32kg): 36–71mg/kg/day, up to max 1.2g/day (800mg in the AM + 400mg in the afternoon); (33–53kg): 37–61mg/kg/day, up to max 2g/day (1200mg in the AM + 800mg in the afternoon); (54–90kg): 27–44mg/kg/day, up to max 2.4g/day (1200mg in the AM + 1200mg in the afternoon).
Monitor renal function before and during therapy. History of renal disease. Monitor for mesalamine-induced acute intolerance syndrome; discontinue if suspected. Sulfasalazine allergy. Pre-existing liver disease. Upper GI tract obstruction. Reevaluate periodically. Elderly (monitor CBCs). Pregnancy (Cat.B). Nursing mothers.
Increased risk of renal reactions with nephrotoxic agents (eg, NSAIDs). Increased risk of blood disorders with azathioprine or 6-mercaptopurine.
Eructation, abdominal pain, constipation, dizziness, rhinitis, back pain, rash, dyspepsia, flu syndrome; acute intolerance syndrome, hypersensitivity reactions (including myocarditis, pericarditis, pneumonitis, hematologic abnormalities, others). Pediatrics: also, nasopharyngitis, headache, sinusitis, cough, diarrhea, fatigue, pyrexia, increased lipase.